UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

August 25, 2021

Commission File Number: 0-29374

EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F [ x]      Form 40-F [  ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: August 25, 2021

EDAP TMS S.A.

 

/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER

 

 


EDAP Reports Second Quarter 2021 Results and Provides Operational Update

- Total revenue for the first half 2021 of EUR 20.7 million (USD $24.8 million) increased 22.5% over the same period of the prior year
- Net income was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, for the first half of 2021
- Cash balance of EUR 45 million (USD $53.3 million) as of June 30, 2021
- Second quarter U.S. HIFU treatment volumes increased 79% over the comparable period in 2020; strong leading indicator of Focal One adoption
- CMS Advisory Panel on Hospital Outpatient Payment (HOP panel), at its summer meeting, unanimously recommended increasing reimbursement for HIFU prostate ablation to APC Level 6 in 2022 from Level 5 currently
- Company to host a conference call tomorrow, August 26, at 8:30 am ET

LYON, France, August 25, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the second quarter of 2021 and provided an update on strategic and operational developments. 

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “We were very pleased during the second quarter to see continued strong growth in U.S. Focal One treatment volumes, a metric that we believe reflects accelerating HIFU adoption as a prostate cancer treatment alternative. While the ongoing COVID pandemic continues to weigh on hospital capital spending, we nonetheless continued to build a robust pipeline of Focal One and ExactVu pipeline opportunities, and we are optimistic that we will close additional high-profile sales this year.

“On the reimbursement front, just a few days ago, the CMS HOP panel voted unanimously in favor of increasing reimbursement for HIFU prostate ablation to APC Level 6 next year from Level 5 currently. Even if the HOP panel has only an advisory role to CMS, we believe this is a strong signal and further recognition of the value of HIFU in this indication. We hope this will be taken into account by CMS when building the final rule, which will be published in December of this year. If this is the case, reimbursement for Focal One HIFU would increase from an average of approximately $4,500 per procedure this year to an average of approximately $8,500 per procedure in 2022. This increase, if implemented, could be a significant catalyst to accelerating Focal One sales in 2022 and beyond.

“Importantly, our U.S. expansion plans, led by new U.S. subsidiary CEO Ryan Rhodes, are progressing and we are well financed with more than $53 million on our balance sheet. I believe we are poised for a strong back half of the year and accelerating HIFU momentum heading into 2022.”

For the first six months 2021 Results

Total revenue for the first half of 2021 was EUR 20.7 million (USD 24.8 million), an increase of 22.5% compared to total revenue of EUR 16.9 million (USD 18.7 million) for the same period in 2020.

Total revenue in the HIFU business for the first six months of 2021 was EUR 3.8 million (USD 4.6 million), a decline of 15.1% as compared to EUR 4.5 million (USD 4.9 million) for the first six months of 2020.

Total revenue in the LITHO business for the first six months of 2021 was EUR 5.2 million (USD 6.2 million), a decline of 11.8% from EUR 5.9 million (USD 6.5 million) for the first six months of 2020.

Total revenue in the Distribution business for the first six months of 2021 was EUR 11.7 million (USD 14.0 million), a 79.0% increase compared to EUR 6.5 million (USD 7.2 million) for the first six months of 2020.

Gross profit for the first six months of 2021 was EUR 8.6 million (USD 10.3 million), compared to EUR 7.4 million (USD 8.2 million) for the year-ago period. Gross profit margin on net sales was 41.6% in the first six months of 2021, compared to 43.9% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 8.8 million (USD 10.5 million) for the first six months of 2021, compared to EUR 8.5 million (USD 9.5 million) for the same period in 2020.

Operating loss for the first six months of 2021 was EUR 0.2 million (USD 0.2 million), compared to an operating loss of EUR 1.2 million (USD 1.3 million) for the same period in 2020.

 

 

Net income for the first six months of 2021 was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, as compared to a net loss of EUR 1.5 million (USD 1.6 million), or EUR (0.05) per diluted share in the year-ago period.

As of June 30, 2021, the company held cash and cash equivalents of EUR 45 million (USD 53.3 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Second Quarter 2021 Results

Total revenue for the second quarter 2021 was EUR 10.4 million (USD 12.4 million), an increase of 11.8% compared to total revenue of EUR 9.3 million (USD 10.3 million) for the same period in 2020.

Total revenue in the HIFU business for the second quarter 2021 was EUR 2.0 million (USD 2.4 million), a decline of 21.8% as compared to EUR 2.6 million (USD 2.8 million) for the second quarter of 2020.

Total revenue in the LITHO business for the second quarter 2021 was EUR 2.3 million (USD 2.7 million), a decline of 22.6% from EUR 2.9 million (USD 3.2million) for the second quarter of 2020.

Total revenue in the Distribution business for the second quarter 2021 was EUR 6.1 million (USD 7.3 million), a 61.6% increase compared to EUR 3.8 million (USD 4.2 million) for the second quarter of 2020.

Gross profit for the second quarter 2021 was EUR 4.2 million (USD 5.1 million), compared to EUR 4.3 million (USD 4.8 million) for the year-ago period. Gross profit margin on net sales was 40.7% in the second quarter of 2021, compared to 46.8% in the year-ago period.

Operating expenses were EUR 4.6 million (USD 5.6 million) for the second quarter of 2021, compared to EUR 4.0 million (USD 4.5 million) for the same period in 2020.

Operating loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) in the second quarter of 2020.

Net loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), or EUR (0.01) per diluted share, as compared to a net loss of EUR 0.2 million (USD 0.2 million), or EUR (0.01) per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, August 26, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

 

Conference Call & Webcast
Thursday, August 26, 2021 @ 8:30am Eastern Time

Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13721942
Webcast: http://public.viavid.com/index.php?id=145982

Following the live call, a replay will be available on the Company's website, www.edap-tms.com under "Investors Information."

 

 

 

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as the length and severity of the COVID-19 pandemic, including its impacts across our businesses on demand for our devices and services. Factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

 

Company Contact

Blandine Confort

Investor Relations / Legal Affairs

EDAP TMS SA

+33 4 72 15 31 50

bconfort@edap-tms.com

 

Investor Contact

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

 

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of Euros and U.S. Dollars, except per share data)

    Three  Months Ended:   Three Months Ended:
   

June. 30,

2021

Euros

 

June. 30,

2020

Euros

 

June. 30,

2021

$US

 

June. 30,

2020 

$US
Sales of medical equipment     6,696       5,975       8,051       6,628  
Net Sales of RPP and Leases     1,265       947       1,521       1,050  
Sales of spare parts, supplies and Services     2,387       2,311       2,870       2,564  
TOTAL NET SALES     10,349       9,233       12,443       10,242  
Other revenues     1       23       2       25  
TOTAL REVENUES     10,350       9,255       12,445       10,267  
Cost of sales     (6,134 )     (4,931 )     (7,376 )     (5,470 )
GROSS PROFIT     4,216       4,324       5,069       4,797  
Research & development expenses     (925 )     (926 )     (1,112 )     (1,027 )
S, G & A expenses     (3,718 )     (3,096 )     (4,470 )     (3,434 )
Total operating expenses     (4,642 )     (4,022 )     (5,582 )     (4,461 )
OPERATING PROFIT (LOSS)     (427 )     303       (513 )     336  
Interest (expense) income, net     (20 )     (19 )     (25 )     (21 )
Currency exchange gains (loss), net     82       (346 )     98       (384 )
Other income, net     —         (1 )     —         (1 )
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     (365 )     (63 )     (439 )     (70 )
Income tax (expense) credit     (58 )     (112 )     (70 )     (124 )
NET INCOME (LOSS)     (424 )     (175 )     (509 )     (194 )
Earning per share – Basic     (0.01 )     (0.01 )     (0.02 )     (0.01 )
Average number of shares used in computation of EPS     32,220,414       29,141,566       32,220,414       29,141,566  
Earning per share – Diluted     (0.01 )     (0.01 )     (0.02 )     (0.01 )
Average number of shares used in computation of EPS for positive net income
    32,220,414       29,141,566       32,220,414       29,141,566  

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average three months’ noon buying rate of 1 Euro = 1.2024 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1093 USD

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of Euros and U.S. Dollars, except per share data)

    Six Months Ended:   Six Months Ended:
   

June. 30,

2021

Euros

 

June. 30,

2020

Euros

 

June. 30,

2021

$US

 

June. 30,

2020

$US

Sales of medical equipment     13,387       10,099       16,075       11,173  
Net Sales of RPP and Leases     2,477       2,202       2,975       2,436  
Sales of spare parts, supplies and Services     4,784       4,539       5,744       5,022  
TOTAL NET SALES     20,648       16,841       24,794       18,631  
Other revenues     4       24       5       27  
TOTAL REVENUES     20,653       16,865       24,799       18,658  
Cost of sales     (12,066 )     (9,479 )     (14,488 )     (10,487 )
GROSS PROFIT     8,587       7,386       10,311       8,171  
Research & development expenses     (1,776 )     (1,968 )     (2,132 )     (2,177 )
S, G & A expenses     (6,998 )     (6,575 )     (8,403 )     (7,274 )
Total operating expenses     (8,774 )     (8,543 )     (10,536 )     (9,452 )
OPERATING PROFIT (LOSS)     (188 )     (1,157 )     (225 )     (1,280 )
Interest (expense) income, net     143       (39 )     172       (43 )
Currency exchange gains (loss), net     571       (57 )     685       (63 )
Other income, net     —         0       —         (1 )
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     527       (1,254 )     632       (1,388 )
Income tax (expense) credit     (177 )     (228 )     (213 )     (252 )
NET INCOME (LOSS)     350       (1,483 )     420       (1,640 )
Earning per share – Basic     0.01       (0.05 )     0.01       (0.06 )
Average number of shares used in computation of EPS     30,705,356       29,141,566       30,705,356       29,141,566  
Earning per share – Diluted     0.01       (0.05 )     0.01       (0.06 )
Average number of shares used in computation of EPS for positive net income     31,994,402       29,141,566       31,994,402       29,141,566  

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average six months’ noon buying rate of 1 Euro = 1.2008 USD, and 2020 average six months noon buying rate of 1 Euro = 1.1063 USD


 

 

 

EDAP TMS S.A.

UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

(Amounts in thousands of Euros and U.S. Dollars)

 

   

June 30,

2021

Euros

 

Dec. 31,

2020

Euros

 

June 30,

2021

$US

 

Dec. 31,

2020

$US

Cash, cash equivalents and short-term treasury investments     44,961       24,696       53,272       30,201  
Account receivables, net     11,183       12,339       13,249       15,090  
Inventory     8,610       7,989       10,202       9,771  
Other current assets     618       369       732       451  
TOTAL CURRENT ASSETS     65,372       45,393       77,455       55,513  
Property, plant and equipment, net     5,135       5,599       6,084       6,847  
Goodwill     2,412       2,412       2,858       2,949  
Other non-current assets     1,704       1,790       2,019       2,189  
TOTAL ASSETS     74,622       55,193       88,415       67,498  
Accounts payable & other accrued liabilities     9,297       10,256       11,016       12,543  
Deferred revenues, current portion     3,264       2,701       3,867       3,304  
Short term borrowing     1,447       2,638       1,714       3,227  
Other current liabilities     1,340       5,679       1,588       6,945  
TOTAL CURRENT LIABILITIES     15,348       21,275       18,185       26,018  
Obligations under operating and finance leases non-current     1,415       1,653       1,677       2,022  
Long term debt, non-current     5,215       1,143       6,179       1,397  
Deferred revenues, non-current     826       926       979       1,132  
Other long term liabilities     3,628       3,949       4,298       4,829  
TOTAL LIABILITIES     26,432       28,945       31,317       35,399  
TOTAL SHAREHOLDERS’EQUITY     48,191       26,248       57,098       32,099  
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY     74,622       55,193       88,415       67,498  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1848 USD on June 30, 2021 and at the noon buying rate of 1 Euro = 1.2229 USD on December 31, 2020

 

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands of Euros)

 

   

6-months ended

June 30, 2021

Euros

 

12-months ended

Dec. 31, 2020

Euros

 

6-months ended June 30, 2021

$US

 

12-months ended

Dec. 31 2020

$US

NET INCOME (LOSS)     350       (1,704 )     420       (1,955 )
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)     976       3,790       1,172       4,349  
OPERATING CASH FLOW     1,326       2,087       1,592       2,394  
Increase/Decrease in operating assets and liabilities     (585 )     (110 )     (702 )     (126 )
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES     741       1,977       890       2,269  
Short term investments(2)     —         —         —         —    
Additions to capitalized assets produced by the company and other capital expenditures     (644 )     (2,011 )     (773 )     (2,307 )
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES     (644 )     (2,011 )     (773 )     (2,307 )
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES     20,368       3,201       24,457       3,673  
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS     (199 )     642       (1,503 )     3,118  
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS     20,266       3,810       23,071       6,752  

 


 

(1) including Share based compensation expenses for 180 thousand of Euros at the end of June 2021, and 160 thousand of Euros at the end of December 2020

(2) Short term investments are comprised of money market funds

 

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average six months’ noon buying rate of 1 Euro = 1.2008 USD and at the 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 USD

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

SIX MONTHS ENDED JUNE 30, 2021

(Amounts in thousands of Euros)

 

    HIFU
Division
      ESWL
Division
      Distribution
Division
      Reconciling
Items
  Total After 
Consolidation
   
Sales of goods     1,151               1,881               10,356                       13,387      
Sales of RPPs & Leases     1,798               540               139                       2,477      
Sales of spare parts & services     846               2,755               1,182                       4,784      

TOTAL NET SALES

    3,795               5,176               11,677                       20,648      
Other revenues
    4               0               0                       4      
TOTAL REVENUES     3,799               5,176               11,677                       20,653      

GROSS PROFIT (% of Total Revenues)

    1,501       39.5 %     2,472       47.8 %     4,614       39.5 %             8,587     41.6%
Research & Development     (1,208 )             (418 )             (150 )                     (1,776 )    
Total SG&A plus depreciation     (1,946 )             (1,453 )             (2,689 )             (911 )     (6,998 )    

OPERATING PROFIT (LOSS)

    (1,652 )             601               1,775               (911 )     (188 )    

 

 

 

 

 

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